MAUDE Adverse Event Report: MALEM MALEM ALARM

Device Problems Fire (1245); Material Rupture (1546)

Patient Problems Burn(s) (1757); Pain (1994); Depression (2361)

Event Date 06/04/2017

Event Type  Injury  

Event Description

I ordered a malem bedwetting alarm on (b)(6) which was sold by a seller (b)(6).The alarm was shipped to me via 2 day shipping.The malem alarm is a cheaply made gadget that has harmed my son more than it can do any good to him.My son had physical harm with this product which is extremely painful and scary.The very first night we used the malem alarm, in the deep hours of the night, the alarm exploded and burnt my son's neck.The alarm literally caught fire.We had to rush him to the urgent care at night.My son is so scared that he refuses to even play with some of his toys as he feels that they may also get hot and burn his hands.I don't know for how long he will be scared like this but for me it is more like depression.(b)(6) has removed the malem alarm for safety reasons after many parents wrote similar reviews and shared experiences like this on the website.The mfr has put a deaf ear to all our comments and complaints.I reached out to (b)(6) and they forwarded me to the seller who has not replied even once to my complaint.It appears that the product is dangerous and risky for children.They simply make money by fooling buyers instead of thinking of children's safety first.I appreciate your prompt attention into this delicate matter.

• Brand Name: MALEM ALARM
• Type of Device: MALEM ALARM
• Manufacturer (Section D): MALEM
• MDR Report Key: 6633362
• MDR Text Key: 77322041
• Report Number: MW5070296
• Device Sequence Number: 1
• Product Code: KPN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 06/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR
• Patient Weight: 22